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Trial · NCT00006478

Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

NCT00006478, Phase 2, Terminated, University of Nebraska; results first posted 2010-11-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma. Trials, record NCT00006478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006478

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
NCT number
NCT00006478
Status
Terminated
Phases
Phase 2
Enrollment
19 participants, actual
Lead sponsor
University of Nebraska
Conditions
Lymphoma
Interventions
autologous tumor cell vaccine, keyhole limpet hemocyanin, sargramostim, adjuvant therapy
First posted
2003-01-27
Last updated
2023-09-18
Results first posted
2010-11-17
Limitations and caveats
The Sponsor Genitope suspend development of MyVax in light of the decision made by the FDA March 6, 2008, therefore this trial was halted prematurely leaving insufficient data to analyze.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Humoral and Cellular Immune Response
immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
SecondarySafety of Idiotype VaccineAt each immunization and at study completionTo evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
SecondaryToxicity of Idiotype VaccineAt each immunization and at study completionTo evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
SecondaryChanges in Quantitative Bcl-21 year post transplant evaluation and then annually until disease progressionTo evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Humoral and Cellular Immune Response
immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.
SECONDARYSafety of Idiotype VaccineAt each immunization and at study completionThe study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.
SECONDARYToxicity of Idiotype VaccineAt each immunization and at study completionThe study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.
SECONDARYChanges in Quantitative Bcl-21 year post transplant evaluation and then annually until disease progressionThe study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDVaccine Therapy19
Overall StudyCOMPLETEDVaccine Therapy12
Overall StudyNOT COMPLETEDVaccine Therapy7

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityVaccine Therapy
Total, other adverse eventsVaccine Therapy019
Total, serious adverse eventsVaccine Therapy019

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA036727Buffett Cancer Center Support GrantSWEASY, JOANN B.UNIVERSITY OF NEBRASKA MEDICAL CENTERNATIONAL CANCER INSTITUTE1985 to 2025

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00006478

GET https://conductscience.org/api/trials/v1/NCT00006478/registered